Configurable subshell components in orthopedic devices

ABSTRACT

A coupling device for an orthopedic brace includes an anchoring member for securing to a frame and protruding therefrom, and a subshell arranged to connect to the frame by the anchoring member. The subshell has a locking element for selectively positioning the subshell on the frame at a plurality of locations. The subshell may include an end portion or contoured edge extending beyond a portion of the frame so as to flex relative to the frame.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority of U.S. provisionalapplication Nos. 61/515,502, filed on Aug. 5, 2011, 61/375,380, filed onAug. 20, 2010, and 61/375,392, filed on Aug. 20, 2010. The entirety ofthe disclosures of these provisional applications is incorporatedherein.

FIELD OF THE DISCLOSURE

This disclosure generally relates to orthopedic devices, andparticularly to configurable subshell components in combination withrigid or semi-rigid frame elements in orthopedic devices.

BACKGROUND

Orthopedic braces comprise a broad range of structures and devices usedfor supporting or stabilizing a joint when worn on the body of a user.Orthopedic braces may serve in either preventative or remedial roles. Inthe preventative role, the brace can provide additional support,stability and protection to a healthy joint so as to prevent or minimizeinjury to the joint due to undue stress. On the other hand, in theremedial role, the brace can support and strengthen a weakened joint dueto injury or infirmity, and thereby reinforce the joint to preventfurther injury, or correct or assist the infirmity.

Typically, orthopedic braces include a frame that comprises at least onesupport member. When there are multiple support members, the brace mayinclude rotational hinges that assist and control movement of the limb.Suitable straps may be used to maintain the brace on the limb, and otherfeatures such as pads may be used to relieve pressure of the brace onthe limb and surrounding areas.

A predominant type of orthopedic brace is a knee brace. Knee braces areused to stabilize the knee by preventing excessive movement of the knee,or to facilitate movement of the knee. Many braces comprise a frame andhave hinges located on at least one of the lateral and medial sides ofthe knee joint. Straps are used to secure the brace to the leg or knee.An injured knee can be fit with an “off the shelf” brace or a“custom-fit” brace, with the selection of the type of brace depending onthe size and shape of an individual's leg.

Many knee braces are designed to reduce knee instability following aninjury, fatigue or to treat impairment of the knee, particularly if theknee has damaged ligaments. Braces may be recommended for walking,skiing, running, twisting, pivoting, or jumping activities. In additionto providing increased stability to the knee, braces may also decreasethe risk of injuring the knee or leg, or provide corrective assistanceto the knee.

In order to maximize its supportive, protective and comfort aspects, itis desirable that a knee brace securely and precisely fit the leg of thewearer. While custom-fit braces are made to closely conform to the exactgeometry of a leg of a wearer, it is common for the geometry of the legto change over time thereby requiring even a custom-fit to be able toaccommodate a variety of geometries of the leg. As for off-the-shelfbraces, these braces must be configurable to generally accommodate avariety of leg geometries irrespective of the particular geometry of aleg.

In recognizing the need for effective knee braces, various knee braceshave been introduced into the marketplace. Such knee braces, however,have generally comprised relatively heavy, bulky apparatuses that failto provide ventilation and evenly distribute pressure from the brace onthe leg of the wearer. Moreover, many contemporary braces are deficientin that the braces are constructed in a manner that do not consistentlyprovide or lack adjustment features for forming a firm, comfortable andsecure interface between the leg and knee of the wearer and the brace.As a result of these drawbacks, many knee braces detract from the user'sendeavor.

The features of the embodiments described herein are provided inrecognition of the need for orthopedic braces and components for usetherewith that are adjustable in both custom-fit and off-the-shelfbraces so as to achieve superior functional performance characteristicswhile being comfortable to the wearer when worn. This recognition isrealized with the invention described hereinafter.

SUMMARY

In an embodiment of an orthopedic device according to the invention, thedevice includes a rigid frame having a peripheral contour and first andsecond side portions, in which the frame is configured to conform to atleast a portion of anatomy of a wearer. The device further includes aflexible subshell secured to the frame, and having a first end extendinglaterally beyond the first side portion so as to flex relative to thefirst frame side portion. The subshell has a contoured edge extendingbeyond the peripheral contour so as to flex relative to the frameperipheral contour. The subshell may be mounted along an interiorsurface of the frame. A strap has a first end secured to the firstsubshell end and a second end connected to the second frame sideportion.

The subshell may have a second end flexibly extending beyond the secondframe side portion, and the strap is secured to the second subshell endwherein tensioning of the strap draws the first and second subshell endstoward one another and away from the frame.

In a variation of the subshell, the subshell may have a living hingespaced inwardly from the contoured edge and permits flexing of thecontoured edge relative to the frame peripheral contour. The livinghinge is defined at least in part by an elongate groove generallydefined by the outline of the contoured edge. In another variation ofthe subshell, the subshell defines a living hinge spaced inwardly fromthe contoured edge extending along a upper segment of a length of thesubshell and further extends generally downwardly toward a lower segmentof the subshell length at the first subshell end.

The subshell end may define a slot generally normal to the length of thesubshell, and the living hinge may be defined at least in part by anelongate groove generally defined by the outline of the contoured edgeand runs along the slot. In a variation, the subshell may have a seriesof openings generally parallel to the slot.

The frame may define a plurality of locating holes, and the subshell canbe adjustably mounted at the plurality of locating holes so as to adjustthe subshell relative to the height of the frame.

In a variation of the frame, the frame defines at least one anchoringmember extending from an interior surface, and the subshell defines atleast one eyelet having a retaining member extending therein. The atleast one eyelet is configured for receiving the at least one anchoringmember and the retaining member arranged for engaging the at least oneanchoring member in the eyelet.

Various embodiments of a tibial subshell assembly are disclosed hereinincluding certain tibial subshells connected to different strappingsystems for distributing pressure over the tibia of the wearer.

An embodiment of a leg wrap is described herein in combination with abrace frame wherein a portion of the leg wrap is adjacent to a rigid orsemi-rigid brace frame. The leg wrap extends about the entirety of thecircumference of the wearer's leg.

In another embodiment, a coupling device for an orthopedic braceincludes a brace frame having an anchoring member protruding therefrom,and a subshell or retention member connected to the brace frame. Thesubshell or retention member has a locking element defining a receivingopening arranged to receive the anchoring member and an engaging openinghaving a width less than the receiving opening, and arranged to engagethe anchoring member depending from the receiving opening. The subshellor retention member also has a retaining member extending into theengaging opening. The retaining member flexibly depends from thesubshell or retention member such that when the receiving openingreceives the anchoring member, the retaining member deflects away fromthe receiving opening, wherein when the anchoring member is moved to theengaging opening, the retaining member retains the anchoring member inplace.

According to a variation, the anchoring member may be adjustablerelative to interior and exterior sides of the brace frame. Further, thebrace frame may include recessed portions to accommodate a portion ofthe anchoring member.

BRIEF DESCRIPTION OF THE DRAWINGS

The orthopedic device is described with reference to the accompanyingdrawings which show preferred embodiments according to the devicedescribed herein. It will be noted that the device as disclosed in theaccompanying drawings is illustrated by way of example only. The variouselements and combinations of elements described below and illustrated inthe drawings can be arranged and organized differently to result inembodiments which are still within the spirit and scope of the devicedescribed herein.

FIG. 1 is an elevational view showing an embodiment of an orthopedicdevice in the form of a knee brace.

FIGS. 2A and 2B are elevational views showing lateral and medial sidesof a variation of the knee brace of FIG. 1.

FIG. 3 is a plan view showing an embodiment of an upper subshell in theknee brace of FIG. 1.

FIG. 4 is an enlarged sectional elevational view showing a section IV-IVof the subshell depicted in FIG. 3.

FIG. 5 is a plan view showing an embodiment of the lower subshell in theknee brace of FIG. 1.

FIG. 6 is an enlarged sectional view taken from FIG. 5.

FIG. 7 is an elevational view of a variation of a tibial subshellassembly.

FIG. 8 is an elevational view of another variation of a tibial subshellassembly.

FIG. 9 is a perspective view of another variation of the tibial subshellassembly.

FIG. 10 is a perspective view of another variation of a tibial subshellassembly.

FIG. 11 is a perspective view of a lower leg wrap showing in an openconfiguration.

FIG. 12 is a perspective view of the lower leg wrap of FIG. 11 in aclosed configuration.

FIG. 13 is an embodiment of a D-ring for use in an orthopedic device.

FIG. 14 is a schematic view showing attachment of the D-ring of FIG. 13on one of a plurality anchoring members on an orthopedic device.

FIG. 15 is a schematic view showing a movable anchoring member in aninterior mounted configuration.

FIG. 16 is a schematic view of the anchoring member of FIG. 15 in anexterior mounted configuration.

FIG. 17 is a schematic view showing a variation of the anchoring memberon a frame element when secured with a D-ring.

FIG. 18 is a sectional view taken along line XVIII-XVIII in FIG. 1.

DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS A. Overview

A better understanding of different embodiments of the invention may behad from the following description read in conjunction with theaccompanying drawings in which like reference characters refer to likeelements.

While the disclosure is susceptible to various modifications andalternative constructions, certain illustrative embodiments are shown inthe drawings and are described below in detail. It should be understood,however, that there is no intention to limit the disclosure to thespecific embodiments disclosed, but on the contrary, the intention is tocover all modifications, alternative constructions, combinations, andequivalents falling within the spirit and scope of the disclosure.

It will be understood that, unless a term is expressly defined in thispatent to possess a described meaning, there is no intent to limit themeaning of such term, either expressly or indirectly, beyond its plainor ordinary meaning.

Any element in a claim that does not explicitly state “means for”performing a specified function, or “step for” performing a specificfunction, is not to be interpreted as a “means” or “step” clause asspecified in 35 U.S.C. §112, paragraph 6.

B. Definitions

For ease of understanding the disclosed embodiments of an orthopedicdevice, the anterior and posterior portions of the orthopedic device aredescribed independently. It will be recognized that the anterior andposterior portions of the orthopedic device function together to supportand stabilize anatomical portions of the wearer of the device.

For further ease of understanding the embodiments of an orthopedicdevice as disclosed herein, a description of a few terms is necessary.As used herein, the term “proximal” has its ordinary meaning and refersto a location situated next to or near the point of attachment or originor a central point, or located toward the center of the body. Likewise,the term “distal” has its ordinary meaning and refers to a location thatis situated away from the point of attachment or origin or a centralpoint, or located away from the center of the body. The term “posterior”also has its ordinary meaning and refers to a location that is behind orto the rear of another location. Lastly, the term “anterior” has itsordinary meaning and refers to a location that is ahead of or to thefront of another location.

The terms “rigid,” “flexible,” “compliant,” and “resilient” may be usedherein to distinguish characteristics of portions of certain features ofthe orthopedic device. The term “rigid” is intended to denote that anelement of the device is generally devoid of flexibility. Within thecontext of frame or support members or shells that are “rigid,” it isintended to indicate that they do not lose their overall shape whenforce is applied, and in fact they may break if bent with sufficientforce. On the other hand, the term “flexible” is intended to denote thatfeatures are capable of repeated bending such that the features may bebent into retained shapes or the features do not retain a general shape,but continuously deform when force is applied.

The term “compliant” is used to qualify such flexible features asgenerally conforming to the shape of another object when placed incontact therewith, via any suitable natural or applied forces, such asgravitational forces, or forces applied by external mechanisms, forexample, strap mechanisms. The term “resilient” is used to qualify suchflexible features as generally returning to an initial general shapewithout permanent deformation. As for the term “semi-rigid,” this termis used to connote properties of support members or shells that providesupport and are free-standing; however such support members or shellsmay have some degree of flexibility or resiliency.

C. Various Embodiments of the Orthopedic Device and Components for UseTherewith

FIG. 1 illustrates an orthopedic device in the exemplary form of a kneebrace 10 having configurable subshell components in combination withrigid frame elements. The knee brace 10 includes an upper frame element12 and a lower frame element 14 connected by lateral and medial hinges16 having condyle pads 35. Preferably, the upper and lower frameelements are either rigid or semi-rigid. As an example, the frameelements may be formed from aluminum and may be malleable from a coldforming treatment so as to allow for easy customization of the frameelements to a particular leg shape. Other exemplary materials that maybe used for constructing the frame include metals such as titanium, andsteel, thermoset resin composite systems including glass or carbonfibers, and thermoplastics that have been rendered rigid by way ofmaterial composition and geometry of the frame members.

According to this embodiment, the upper frame element 12 issubstantially rigid and is adapted to extend along portions of thelateral and medial sides of a leg and about the anterior portion of thethigh. Specifically, the upper frame element 12 includes a lateralupright section 13, a medial upright section 15, and a curved section 17extending between the upper end portions of the lateral and medialuprights 13, 15. According to this embodiment, the curved section 17spirals between the lateral and medial uprights 13, 15 since the medialupright 15 has a shorter length than the lateral upright 13. The curvedsection is “curved” in the sense that it is adapted to curve about atleast part of the anterior circumference of the wearer's leg.

The lower frame element 14 is substantially rigid and is adapted toextend along portions of the lateral and medial sides of the leg andabout the anterior portion of the tibia of the lower leg. The lowerframe element 14 includes a lateral upright 36, a medial indented member42 located at a medial side upper end, a medial upright 38, and ananterior curved section 40 extending between the lower end portions ofthe lateral and medial uprights 36, 38.

The illustrated example of the upper and lower frame elements shows eachframe element as being formed integrally. However, those of skill in theart will appreciate that these components could be formed separately andbe secured to one another with welds, fastening members, etc. Moreover,while the upper and lower frame elements are depicted and described ashaving a particular configuration, the configuration may be modified toextend along different portions of the leg (i.e., posterior) and mayhave different length relationships (i.e., lateral upright versus medialupright).

A flexible upper subshell 18 is mounted onto an interior surface of theupper frame element 12. A strap 28 connects to opposed sides of thesubshell and extends about the posterior side of the knee brace 10. Theupper subshell 18 extends proximate to a segment of the curved section17, such that a medial portion 48 of the upper subshell 18 terminatesprior to the medial upright 15. A flexible lower subshell 20 is mountedonto an interior surface of a lower frame element 14, and a strap 34connects to opposed sides of the lower subshell 20. Because the upperand lower subshells 18, 20 are flexible, when the straps 28, 24 aretensioned, opposed end portions of the subshells connecting to thestraps are drawn toward one another.

Both the upper and lower subshells 18, 20 are sized and configured sothat a portion of peripheral edges of the subshells extends beyond theperipheral edges of the upper and lower frame elements 12, 14. Forexample, an upper peripheral edge 43 of the upper subshell 18 is spacedby a distance 44 from an upper peripheral edge 41 of the upper frameelement 12. In another example, a lower peripheral edge 47 of the lowersubshell 20 extends a distance 46 beyond the lower peripheral edge 45 ofthe lower frame element 20. Because the subshells are flexible, theportions of the subshells extending beyond the peripheral edges of theframe portion are arranged for flexing relative to the rigid frameelements. Other examples, such as end portions of the subshells arrangedto receive straps, will be discussed in greater detail in connectionwith more specific examples of the upper and lower subshells.

The subshells are adjustably mounted to a variety of locations on theframe elements. For example, the upper subshell 18 can be mounted at oneof the two locating apertures 50, 51, extending from the interiorsurface of the upper frame element which enables for adjustment of thedistance 44 between the upper peripheral edge 43 of the upper subshell18 and the upper peripheral edge 41 of the upper frame element 12.

The knee brace 10 includes D-rings 24, as will be explained in greaterdetail in connection with FIGS. 13 and 14, which are arranged to carryposterior straps 30, 56 between the lateral and medial sides of the kneebrace. In addition, the D-rings may be mounted at a plurality oflocations along an interior surface of the upper and lower frameelements, as exemplified with D-rings 24A and strap 30A at a firstlocation, and D-rings 24B and strap 30B at a second location along thelength of the upper frame element.

The knee brace 10 also comprises a tibial subshell 26 that is adjustablymounted on a strap 32 secured between the lower lateral and medialuprights 36, 38. The tibial subshell 26 is preferably constructed from aflexible polymeric material but sufficiently rigid to provide support,and arranged to provide support to the tibia of the wearer. The tibialsubshell 26 includes a pad 52 mounted on its interior surface adjacentthe wearer. Further, the tibial subshell 26 defines an upper peripheryhaving a recessed portion 57 arranged to correspond to the tibia withpeak portions 59 located on opposed sides of the recessed portion 57 soas to better conform to the anatomy of the lower leg.

The tibial subshell is adjustable so that its location can be adjustedrelative to the preferred location for an individual wearer of thebrace. The center of the brace may not necessarily align with the tibiaof the wearer. This configuration is advantageous in that the wearer canadjust the location of the subshell so that it can always or mostly becentered on the tibia of the wearer.

FIGS. 2A and 2B illustrate a variation of the upper and lower frameelements 14 secured to one another via lateral and medial hinges 16. Theupper frame element 14 defines strengthening ribs 21, 23 formed onlateral and medial sides of the lateral and medial uprights 13, 15. Thestrengthening ribs preferably protrude from the outside of the lateraland medial uprights, and are generally parallel with the length of thelateral and medial uprights, and centrally located within the width ofthe uprights. The lower lateral upright 36 forms a strengthening rib 25,whereas the lower medial upright 38 lacks a strengthening rib.

The strengthening ribs provide additional strength to the upper andlower frame elements, as considered necessary when the frame elementsare inherently less rigid; for example, in aluminum based frame elementswhich are generally lightweight and cold or heat moldable. Thestrengthening ribs may be located along various portions of the upperand lower frame elements, and the configuration is not limited to thedepiction in FIGS. 2A and 2B.

The upper medial upright 15 defines a slot 27 for receiving the strap30A, and the upper lateral upright 13 defines apertures 33 for securingattachments, for example b-rings, for connecting to the strap 30A on theupper lateral upright 13. The slots may be replaced by the apertures forsecuring attachments, or provided in combination with the slots. Thelower lateral and medial uprights 36, 38 likewise define slots 29, 31for receiving the strap 32.

Turning to FIGS. 3 and 4, an embodiment of the upper subshell 18 isdepicted in greater detail. The upper subshell 18 defines lateral andmedial portions 62, 64, whereby each portion defines a slot 76, 78,respectively, for receiving a strap (as in strap 28 in FIG. 1) andgenerally perpendicular to the length of the subshell. Both the lateraland medial portions 62, 64, are arranged to extend beyond the peripheryof the upper frame element generally toward a posterior direction of thebrace. Particularly, the slots 76, 78 are configured so that they canbend upon tensioning of the strap and flex relative to the upper frameelement.

Each of the slots 76, 78 defines a reinforced edge 84, 86, respectively,raised from the subshell thickness and arranged to reinforce thesubshell from the strap. Moreover, the medial portion 64 defines aplurality of elongate openings 80 provided in part to ventilate thesubshell as well as facilitate bending of the subshell relative to theframe element.

The upper subshell 18 defines a periphery that conforms, at least inpart, to the contours of the upper frame element, as shown in FIG. 1.For example, the upper subshell 18 defines a lateral upper curvedsection 66 corresponding to the peripheral contour of the lateral sideof the upper frame element, as well as a recessed upper curved section68 corresponding in part to the downwardly spiral of the curved segmentof the upper frame element. The upper subshell 18 also defines a lowercurved section 69 generally conforming to a portion of the contour ofthe upper frame element.

In view of the downward curvature of the upper frame element, and inorder to maintain the strap as extending generally laterally orhorizontally across a thigh of the wearer, the upper subshell 18includes an upwardly medial curved section 74 extending from therecessed curved section 68. Additionally, a downward extension 70terminates the lower curved section 69, whereas an upward extension 72depends from the downward extension 70 and generally conforms to theupwardly medial curved section 74.

The upper subshell 18 defines an elongate flexure feature or livinghinge 82 spaced downwardly from the upper peripheral edge 43, andgenerally corresponding to the lateral upper curved section 66, therecessed curved section 68, and the contours of the medial portion 64 ofthe upper subshell 18. The flexure feature 82 is defined by its contouras well as interior and exterior surface grooves 88, 90 formed on theinterior and exterior surfaces of the subshell.

The flexure feature 82 is preferably aligned along the peripheral edgeof the frame element so the upper peripheral edge 43 of the uppersubshell can extend the distance away from the peripheral edge of theframe element. The flexure feature 82 assists the subshell to flexrelative to the frame element in order to provide added relief to thewearer and minimize the frame element from cutting into or deeplyindenting the leg of the wearer.

The upper subshell 18 forms lateral and medial side locating apertures81, 85 having reinforced sections 83, 87, respectively, therearound. Thelocating aperture 81 forms an elongate slot permitting lateral orhorizontal adjustment of the subshell relative to the upper frameelement. As shown in FIG. 1, apertures 50, 51 at two successive heightlocations can receive fasteners, such as a binding nut, to engage thelocating aperture 81 so as to adjust the location of the upper subshellrelative to the frame element.

The adjustability of the subshell is particularly advantageous in orderto provide a more customizable fit of the subshell relative to the frameelements. For example, with the upper subshell 18 fixedly secured (atone end) to the upper frame element 12, the curvature of the uppersubshell 18 relative to the curved section 17 may be adjustedaccordingly to the geometry of the thigh of the wearer of the brace.

FIGS. 5 and 6 depict an embodiment of the lower subshell 20. The lowersubshell 20 defines lateral and medial portions 101, 102, whereby eachportion defines a slot 104, 106, respectively, for receiving a strap (asin strap 34 in FIG. 1) and generally perpendicular to the length of thesubshell. A reinforced edge 122 surrounds each of the slots 104, 106.

Both the lateral and medial portions 101, 102, are arranged to extendbeyond the periphery of the upper frame element generally toward aposterior direction of the brace. Particularly, the slots 104, 106 areconfigured so that they can bend upon tensioning of the strap and flexrelative to the upper frame element.

The lower subshell 20 defines upper and lower curved peripheral edges112, 47, respectively, that correspond to the contours of the peripheraledges of the lower frame element, as in lower peripheral edge 45. Aswith the upper subshell, the lower subshell 20 includes a flexurefeature or living hinge 118 formed by example from an elongate groove,as well as lateral and medial elongate openings 108, 110 formedgenerally parallel to the slots 104, 106 to provide ventilation andflexure for the lateral and medial portions 101, 102.

The lower subshell 20 defines a locking element 114 having a retainingmember 116, and which is arranged to secure to an anchoring member 120mounted along one of the frame elements. The anchoring members 120 maybe fixedly secured to the frame uprights, or may be releasably securableto the frame uprights, such as by threadable engagement with theuprights, as shown in FIG. 14 with threads 155 formed along theanchoring member and received by corresponding threads of the frameupright. Preferably, as shown in FIG. 5, the lower subshell 20 defines apair of locking elements 114 adapted to secure to the lower frameelement.

Particularly, the locking element 114 defines a receiving opening 124arranged to receive the anchoring member 120 and an elongate engagingopening 126 having a width less than the receiving opening 124 anddepends from the receiving opening 124. The configuration of thereceiving opening 124 relative to the engaging opening 126 permitsinserts of the anchoring member 120 into the locking element 114 andretention of the anchoring member therewithin.

The retaining member 116 flexibly depends from the subshell 20 such thatwhen the receiving opening 124 receives the anchoring member 120, andthe retaining member 116 deflects away from the receiving opening 124,wherein when the anchoring member 120 is moved in direction 128 to theengaging opening 126 whereat the retaining member 116 retains theanchoring member 120 in place.

The retaining member 116 comprises an extension portion 134 dependingfrom the subshell and extends into the receiving opening 124. A headportion 130 depends from the extension portion 134 into the receivingopening 124 and generally conforms to the shape of the receiving opening124. An arcuate recessed portion 132 is formed along the head portion134 and is adjacent to and borders the engaging opening 126. When theanchoring member 120 is located in the engaging opening 126, therecessed portion 132 is arranged to be flush against a peripheral edgeof the anchoring member 120. The extension portion 134 permits flexureof the retaining member 116 out from the receiving opening 124.

The locking element 114 defines an insert region 136 generally alongsidethe engaging portion 126 and formed from a reduced thickness area of thesubshell. The insert region 136 is arranged to receive portions of theanchoring member laterally adjacent to the engaging portion 126 so as toreduce extension of the anchoring member from the subshell.

FIG. 7 depicts a variation of the tibial subshell 26 according toFIG. 1. In this variation, the tibial subshell assembly 111 includes thebasic tibial subshell 26 which is incorporated with a liner 115 securedto a posterior or rear side of the lower frame element 14. A stem 117bridges the portions of liner 115 adjacent the lower frame element 14 tothe tibial subshell 26 and extends generally centrally from the anteriorcurved section 40. The tibial subshell 26 is preferably surrounded bythe liner 115 by the border portion 119, and the rear portion of thetibial subshell is likewise covered by the liner 115. The front side ofthe tibial subshell 26 is preferably exposed and uncovered by the liner115.

The tibial subshell 26 is connected to the lateral and medial uprights36, 38 by the strap 32. In this embodiment, the strap 32 is securedunder and over slots or other attachments to the lateral and medialuprights 36, 38. The strap is preferably inelastic so as to provideconsistent posterior force on the tibia of the wearer when the strap 32is tensioned.

The liner may be formed from a variety of different materials such ascushioning materials or combinations thereof. For example, the liner maybe formed according to any of the embodiments described in U.S. patentapplication Ser. No. 12/774,882, filed on May 6, 2010, and incorporatedherein by reference.

The stem allows for additional stability of the tibial subshell over thetibia of the wearer, and the extension of the liner allows for morecushioning over the tibia. In an alternative, the stem may be replacedby a strap which allows for height adjustment of the tibial subshellover the tibia, with a slot or other attachment means being provided onthe anterior curved section.

FIG. 8 shows another variation of the tibial subshell assembly 121having the tibial subshell 26. In this variation, the tibial subshell 26is pivotally connected to the anterior curved section 40 by a stem 125,and the tibial subshell 26 is pivotally connected to the stem 125 at theupper pivot device 123, so as to be adjustably positioned along thelength of the stem 125 at the locking positions 127.

The upper pivot device 123 may be adjustably loosened so as to permitadjustment of the tibial subshell 26 at the various the lockingpositions 127. For example, the upper pivoting device 123 can be shapedso that turning it in one direction will allow the locking device toslide along a slot 135 formed along the stem 125, but upon turning in anopposite direction, the locking device 125 secures at apertures 127.Other configurations may be used such as ratcheting devices or otherknown systems available to the skilled artisan.

The stem 125 may be pivotally secured to the anterior curved section 40at lower pivot point 129. In addition, the anterior curved section mayinclude a slot 131 provided with or without the locking positions 137 onthe stem 125. In the configuration wherein the slot is open withoutadditional elements, the step can slide relative to the anterior curvedsection.

It will be noted that the stem may be selectively connected to thetibial subshell either at the upper or lower pivot points or the stemmay be secured to the tibial subshell at fixed points.

In another embodiment, the tibial subshell may be formed integrally withthe lower subshell. Taking FIG. 7 for instance, a tibial lower subshellcombination 160 (denoted by the dashed lines for exemplary purposes)includes the tibia subshell 162, a stem 164 and a lower subshell 166,all of which are formed as a single piece.

The tibial lower subshell combination 160 defines strap slots 106 forreceiving straps 32, as in any of the aforementioned embodiments,extending from opposed sides of the uprights which advantageously allowsfor different tensioning on either the lateral or medial sides of thetibia subshell 162. The lateral and medial side straps are particularlyadvantageous over know strap systems whereby a single strap is arrangedto overlie that tibia subshell. In these known systems, there is atendency for the strap to slip from the tibia subshell and come intodirect contact with the leg of the wearer such that the tibia subshellis no longer pressed against the leg of the wearer.

According to any of the embodiments of the tibia subshell, it may beformed of a material, such as ELLASTOLLAN, that is sufficiently soft toallow for trimming of the subshell to the anatomy of the wearer. This isparticularly advantageous in the field setting whereby a clinician canmodify the subshell so as to obtain a more custom fit. Any of thesubshells may be formed from such sufficiently soft materials to betterenable customization of the brace to a particular wearer.

The straps 32 may secure to the lateral and medial uprights 36, 38 muchin the manner in FIG. 7. In an alternative variation, as shown in FIG.8, unlike in the variation of FIG. 7 wherein the straps are secured overthe lateral and medial uprights, the straps are secured over and underthe lateral and medial uprights. In yet another variation, the tibialsubshell may be molded or fixedly secured to a strap secured at opposedends to the lateral and medial uprights.

FIG. 9 illustrates a strap variation of the tibial subshell assembly 111in FIG. 7. Specifically, a strap 139 has a first end 141 secured to thelateral upright 36. The strap 139 feeds through lateral and medial slots143 formed by the tibial subshell 26 with a center portion 147 of thestrap 139 extending over an anterior or exterior surface of the tibialsubshell 26. The strap 139 secures to the medial upright 38, with asecond end 145 of the strap 139 extending freely relative to the medialupright 38. The second end 145 carries hook material (or other suitablefastener), and is securable to the strap 139, including the centerportion 147 exposed over the tibial subshell 26. Pressure is exertedover the tibial subshell 26 and is directed onto the tibia of thewearer, yet pressure is distributed over the wearer's tibia.

In FIG. 10, a variation of the tibial subshell assembly 111 of FIG. 9 isshown, wherein the strap 139 is secured to the tibial subshell 26 in asimilar manner, however both the first and second ends 141 and 145extend freely from the lateral and medial uprights, respectively, andare securable over either each other or the center portion 147 of thestrap 139.

FIG. 10 also illustrates a different structure of the lower frameelement 149. Specifically, the lower frame element 149 includes ananterior curved section 151 with a lateral arm 153 extending therefrom.

FIGS. 11 and 12 show a compliant anti-migration strap wrap 157configured on the lower frame element 149. The wrap 157 defines ageneral shape of the lower frame element 149, and has opposed first andsecond sides 159, 161 proximate to the tibial subshell assembly thatsecure to one another without any corresponding rigid or semi-rigidstructure located on the posterior side of the brace. The first side 159has a longer length extending freely from the lower frame element 149,and wraps at least over the posterior leg of the wearer.

The second side 161 wraps over an exterior surface of the first side sothat the wrap 157 circumferentially extends around the entirety of thelower leg of the wearer, with only the anterior portion of the wrapnecessarily corresponding to rigid or semi-rigid structure. This isparticularly advantageous in that the bony portions, such as the shin onthe anterior side of the lower leg, have corresponding rigid orsemi-rigid structure associated therewith, whereas the fleshy portion ofthe lower leg, such as the calf portion on the posterior side of theleg, has a substantially flexible material associated therewith allowingfor muscles movement, flexibility and comfort.

A strap 163 secures to the exterior surface of both the first and secondsides 159, 161 so as to securely couple them together. Preferably, thestrap 163 includes first and second sides 165, 167 that have a fastener,such as hook material, that permit them to secure to the first andsecond wrap sides 159, 161. A center portion 169 of the strap 163 islocated between the first and second sides 165, 167. The center portion169 may be formed from a stretchable or flexible material so as tobetter accommodate movement of the posterior portion of the wearer'sleg.

The wrap preferably includes a friction medium that engages the lowerleg to prevent movement thereagainst. An example of a type of structureof the wrap can be a compliant spacer element found in U.S. patentapplication Ser. No. 12/774,882.

As illustrated in FIG. 13, an embodiment of a subshell in the form of aD-ring or retention member 24 defines forward and rearward portions 140,142. An elongate slot 148 is formed at the rearward portion 142 of theD-ring 24 and a reinforced edge 156 of types described in connectionwith the subshells is provided around the elongate slot 154. The D-ring24 includes a locking element 146 constructed much in the same manner asthe locking element 114. The D-ring 24 may be flexible so as to conformto the anatomy of a leg of the wearer, or the D-ring 24 may be rigid. Ofnote, the elongate slot 148 is generally perpendicular to the elongateengaging opening 126, which further allows for the anchoring member tobe retained when a strap is inserted through the strap slot andtensioned.

The D-ring 24 has a body 144 with a thickness that is less than areinforced area 146 surrounding the strap slot 148. As a result, thebody 144 area of the D-ring is flexible whereas the reinforced area 146may result in a semi-rigid or rigid section of the D-ring such that theD-ring does not yield to the anatomy of the wearer or brace upon whichit is secured. On the other hand, the reinforced area 146 may beconfigured with a thickness allowing some flexibility to allow theD-ring to conform to the anatomy of the wearer or brace upon which it issecured.

The D-rings described herein may be constructed and formed in any mannerdescribed herein in connection to the subshells, and in any other mannerknown to the skilled person. It will be noted that the D-rings can beformed from rigid or semi-rigid material, as well as material that isflexible.

FIG. 14 depicts an anchoring member 120 having a cap 152 and a stem 154upon which the cap 152 is secured. The cap 152 is arranged to penetratethe head portion 130 of the locking element 114 and rest along theinsert region 136 when the anchoring member 120 is in the engagingopening 126. The cap 152 has a size less than the width of the receivingportion 124 but greater than the width of the engaging opening 126. Theengaging opening 126 is proximate in size to the stem 154 and smaller insize than the cap 152. The engaging opening 126 prevents passage of thecap 152 therethrough.

According to the embodiment and schematic views of FIGS. 15 and 16, ananchoring member 160 is adjustably movable to exterior E or interior Ipositions. The frame element, such as the upper frame element 12 of FIG.1, has a thickness through which a channel or hole 168 is formed. Theanchoring member 160 includes exterior and interior caps 162, 164, witha stem 176 extending therebetween. The stem 176 is sized longer than thechannel 168 so the anchoring member 160 is slidable within the channel168 between the exterior and interior sides. The caps 162, 164 have adiameter greater than the diameter of the channel 168 to they areretained by exterior and interior surfaces of the frame element.

When the anchoring member 160 is pressed with a force F fully towardeither the exterior E or interior I surface of the frame element 12, agap 174 is formed between the one of the surfaces of the frame element12 and one of the caps 162, 164. The gap 174 is sized and configured tosnugly receive a D-ring, such as the D-ring discussed above in referenceto FIGS. 13 and 14, as shown in FIG. 17.

FIG. 17 shows a variation of the embodiment of FIGS. 15 and 16, theframe element 12 may define recesses 170, 172 that are sized larger indiameter than the caps 160, 162, and have a depth greater than thethickness of the caps 160, 162. The recesses 170, 172 allow for the caps160, 162 to form a flush surface in combination with both the exterioror interior surfaces depending on the configuration of the anchoringmember 160, and the side upon which the D-ring 24 is mounted.

It will be noted that the anchoring member 160 is not limited for usewith a D-ring, but it can be used with any number of subshellattachments for the orthopedic device, and be located at any number oflocations along the frame of an orthopedic device.

FIG. 18 illustrates a variation of an interior surface 156 (as opposedto the depiction of exterior surfaces in FIG. 1) of the frame elementsfrom which the anchoring members 120 extend. The anchoring members 120A,120B are arranged in a substantially horizontal configuration, whereasanchoring members 120C, 120D, 120E are arranged in a substantiallyvertical configuration. Advantageously, the tibital strap can be mountedat a variety of heights along the uprights of the frame elements. Otherconfigurations are available as would be considered necessary by theskilled person.

The anchoring members may be formed integrally with the frame elementsor secured to the frame elements with conventional fastening members,such as screws or welding.

While the foregoing embodiments have been described and shown, it isunderstood that alternatives and modifications of these embodiments,such as those suggested by others, may be made to fall within the scopeof the invention. While the orthopedic device has been described in thecontext of a knee brace, it will be understood that any of theprinciples described herein may be extended to other types of orthopedicdevices.

The invention claimed is:
 1. A coupling device for an orthopedic bracehaving a frame element, the device comprising: an anchoring membersecurable to a frame element and arranged to protrude therefrom; asubshell having a locking element, the locking element defining anopening and a retaining member flexibly extending into the opening;wherein the retaining member is defined as an extension segmentdepending from the subshell and extending into 1 receiving portion, ahead portion generally conforming to the shape of the receiving portion,and a recessed portion adjacent to and bordering a engaging portion, theextension segment permitting flexure of the retaining member out fromthe receiving portion.
 2. The coupling device according to claim 1,wherein the opening of the locking element includes a receiving portionarranged to receive the anchoring member and an engaging portion havinga width less than the receiving portion and arranged to engage theanchoring member depending from the receiving portion.
 3. The couplingdevice according to claim 2, wherein the receiving portion receives theanchoring member, the retaining member deflects away from the receivingportion, wherein when the anchoring member is moved to the engagingportion, the retaining member retains the anchoring member in place. 4.The coupling device according to claim 1, wherein the anchoring membercomprises a cap removably receivable within the receiving portion andthe engaging portion.
 5. The coupling device according to claim 1,wherein the anchoring member comprises a stem and a cap located on andwider than the stem.
 6. The coupling device according to claim 5,wherein the receiving portion is proximate in size to the cap such thatthe receiving portion is sized larger than the cap.
 7. The couplingdevice according to claim 5, wherein the engaging portion is proximatein size to the stem and smaller in size than the cap, the engagingportion preventing passage of the cap therethrough.
 8. A coupling devicefor an orthopedic brace having a frame element, the device comprising:an anchoring member securable to a frame element and arranged toprotrude therefrom; a subshell having a locking element, the lockingelement defining an opening and a retaining member flexibly extendinginto the opening; wherein the anchoring member comprises a stem and acap located on and wider than the stem; wherein the locking elementdefines an insert region generally alongside the engaging portion andformed from a reduced thickness area of the subshell, the insert regionarranged to receive portions of the cap laterally adjacent to the stemso as to reduce extension of the cap from the subshell.
 9. A couplingdevice for an orthopedic brace having a frame element, the devicecomprising: an anchoring member securable to a frame element andarranged to protrude therefrom; a subshell having a locking element, thelocking element defining an opening and a retaining member flexiblyextending into the opening; wherein the anchoring member comprises astem, and first and second caps located on opposed ends of the stem;wherein the coupling device further comprises a frame element of anorthopedic device, wherein the anchoring member is adjustably securableto the orthopedic device such that the frame element defines a channel,and the stem slides within the channel between first and second sides ofthe frame element, the anchoring member being delimited in travel by thefirst and second caps.
 10. The coupling device according to claim 9,wherein the frame element defines recessed portions for receiving thefirst and second caps.
 11. An orthopedic device, comprising: a rigid orsemi-rigid frame having a peripheral contour and first and second sideportions; a flexible subshell secured to the frame and overlapping atleast in part with the frame, the subshell including a lateral first endextending laterally beyond the first side portion so as to flex inwardlyrelative to the first frame side portion, the subshell having acontoured edge extending a distance beyond the peripheral contour atareas of overlap between the subshell and the frame so as to flexrelative to the frame peripheral contour; a strap having a first endsecured to the subshell end and a second end connected to the secondframe side portion.
 12. The orthopedic device according to claim 11,wherein the subshell has a second end flexibly extending beyond thesecond frame side portion, the strap secured to the second subshell endwherein tensioning of the strap draws the first and second subshell endstoward one another and away from the frame.
 13. The orthopedic deviceaccording to claim 11, wherein the subshell is mounted along an interiorsurface of the frame.
 14. The orthopedic device according to claim 11,wherein the subshell defines a living hinge spaced inwardly from thecontoured edge and permitting flexure of the contoured edge relative tothe frame peripheral contour.
 15. The orthopedic device according toclaim 14, wherein the living hinge is defined at least in part by anelongate groove generally defined by the outline of the contoured edge.16. The orthopedic device according to claim 14, wherein the subshellend defines a slot generally normal to the length of the subshell, theliving hinge is defined at least in part by an elongate groove generallydefined by the outline of the contoured edge and runs along the slot.17. The orthopedic device according to claim 11, wherein the subshell isa tibial subshell assembly including a tibial subshell extending fromthe frame, and the strap secures to opposed lateral and medial frameportions and corresponding lateral and medial sides of the tibialsubshell with the tibial subshell located between the lateral and medialframe portions.